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Ongoing Clinical Trials for Colorectal Cancer

This article provides detailed information about ongoing clinical trials for colorectal cancer. These trials are investigating new treatments, drug combinations, and therapeutic approaches for patients with various stages of colorectal cancer, including advanced, metastatic, and early-stage disease. The trials cover immunotherapies, targeted therapies, chemotherapy combinations, and novel treatment strategies across multiple countries.

Clinical trial locations

A study comparing TAP block versus QL block with ropivacaine for pain management after laparoscopic colon resection in patients with colon cancer or diverticulosis

This trial compares two methods of pain relief after laparoscopic colon surgery for patients with colon cancer or diverticulosis. Participants will receive either a Transversus Abdominis Plane (TAP) block or a Quadratus Lumborum (QL) block using ropivacaine hydrochloride. Both techniques involve injecting local anesthetic near specific muscles in the abdomen to reduce pain during and after surgery.

Main inclusion criteria: Patients must be between 18 and 99 years old and scheduled to undergo laparoscopic colon resection surgery for either colon cancer or diverticulosis.

Main exclusion criteria: Patients with allergies to local anesthetics, blood clotting disorders, infections at the injection site, significant heart, lung, or liver disease, chronic pain conditions requiring regular opioid medications, or pregnancy.

Trial focus: The study evaluates whether TAP block or QL block provides better pain control, comparing pain levels at various time points after surgery and monitoring patient satisfaction with the pain management approach.

Investigational treatment: Ropivacaine hydrochloride, a local anesthetic administered through either TAP or QL nerve block techniques to control post-operative pain.

Study Comparing Amivantamab and Chemotherapy Versus Cetuximab and Chemotherapy for Patients with Advanced Colorectal Cancer

This trial compares two treatment approaches for advanced colorectal cancer: Amivantamab combined with chemotherapy (mFOLFOX6 or FOLFIRI) versus Cetuximab combined with the same chemotherapy options. The study focuses on patients whose tumors do not have specific genetic mutations (KRAS, NRAS, and BRAF wild-type).

Main inclusion criteria: Patients must have adenocarcinoma of the colon or rectum that is unresectable or metastatic, with confirmed KRAS, NRAS, and BRAF wild-type status. They should have measurable disease and adequate organ function.

Main exclusion criteria: Patients who have received more than 8 weeks of treatment after surgery, those who have been treated with drugs targeting the c-Met protein, or those with active/untreated brain metastases.

Trial focus: The study evaluates which combination treatment is more effective in preventing cancer progression and improving survival rates.

Investigational treatments: Amivantamab (an antibody-drug conjugate targeting specific proteins on cancer cells), mFOLFOX6 and FOLFIRI (chemotherapy regimens), and Cetuximab (an EGFR-targeting therapy).

Study Comparing Amivantamab and Drug Combination for Patients with Recurrent or Metastatic Colorectal Cancer Without KRAS/NRAS and BRAF Mutations

This trial evaluates Amivantamab combined with FOLFIRI chemotherapy compared to Cetuximab or Bevacizumab combined with FOLFIRI in patients whose colorectal cancer has returned or spread. The study focuses on patients whose tumors are KRAS, NRAS, and BRAF wild-type and who have received one line of prior systemic therapy.

Main inclusion criteria: Patients must have documented disease progression after one line of systemic therapy, ECOG performance status of 0-1, measurable disease, and adequate organ function.

Main exclusion criteria: Patients with different types of cancer or who are not eligible for the study-specific treatments.

Trial focus: The study compares progression-free survival and overall survival between the treatment groups.

Investigational treatments: Amivantamab, FOLFIRI chemotherapy, Cetuximab, and Bevacizumab.

Study of 5-Fluorouracil, Panitumumab, and Sotorasib for Patients with Advanced KRAS G12C Mutated Colorectal Cancer Not Eligible for Standard Chemotherapy

This trial tests a combination of 5-fluorouracil, panitumumab, and sotorasib for patients with advanced colorectal cancer who have a specific KRAS G12C mutation and are not eligible for standard chemotherapy. The treatment aims to improve outcomes for this patient population.

Main inclusion criteria: Patients must be at least 18 years old, have a life expectancy of more than 6 months, adequate bone marrow, liver, and kidney function, and a confirmed KRAS G12C mutation.

Main exclusion criteria: Patients with other recent cancers, serious heart problems, uncontrolled high blood pressure, active infections, or pregnancy/breastfeeding.

Trial focus: The study monitors tumor response, quality of life, and treatment tolerability over up to 24 months.

Investigational treatments: 5-fluorouracil (chemotherapy), panitumumab (EGFR-targeting therapy), and sotorasib (KRAS G12C inhibitor).

Study of Amivantamab and Chemotherapy Drug Combination for Patients with Advanced or Metastatic Colorectal Cancer

This trial investigates Amivantamab alone and in combination with standard chemotherapy (including fluorouracil, oxaliplatin, irinotecan, and folinic acid) for advanced or metastatic colorectal cancer. The study has two phases: determining the optimal dose and evaluating effectiveness.

Main inclusion criteria: Patients must be 18 years or older with unresectable or metastatic colorectal adenocarcinoma, wildtype KRAS, NRAS, and BRAF, measurable disease, ECOG performance status 0-1, and adequate organ function.

Main exclusion criteria: Patients receiving other experimental drugs, with active infections, pregnant/breastfeeding, or with recent major surgery.

Trial focus: The study evaluates safety, tolerability, and antitumor activity of Amivantamab with chemotherapy.

Investigational treatment: Amivantamab combined with various chemotherapy regimens.

Study of AZD9574 and Temozolomide for Patients with Advanced Solid Tumors, Including Breast, Ovarian, Pancreatic, and Prostate Cancers

This trial tests AZD9574, a DNA Helicase Werner Inhibitor, both alone and combined with other anti-cancer treatments. The study includes patients with various advanced solid tumors, including colorectal cancer, that have specific genetic characteristics (dMMR or MSI-H).

Main inclusion criteria: Patients must be at least 18 years old, have an ECOG performance status of 0-2, a life expectancy of at least 12 weeks, and adequate organ and bone marrow function.

Main exclusion criteria: Patients with active brain metastases, significant heart conditions, inflammatory bowel disease, BMI above 40, or participation in another trial within 30 days.

Trial focus: The study assesses safety, tolerability, and effectiveness of AZD9574 alone and in combination with other treatments.

Investigational treatment: AZD9574 (Werner Helicase inhibitor) with or without other anti-cancer agents.

Study of BOLD-100 with FOLFOX chemotherapy (fluorouracil, folinic acid, and oxaliplatin) in patients with advanced gastrointestinal tumors, colorectal, gastric, or pancreatic cancer

This study evaluates BOLD-100 combined with FOLFOX chemotherapy for patients with advanced gastrointestinal tumors, including colorectal cancer. The trial is conducted in two parts: dose-finding and expansion to assess effectiveness.

Main inclusion criteria: Patients must be 18 years or older with unresectable metastatic colorectal cancer, adequate organ function, and specific prior treatment history depending on cancer type.

Main exclusion criteria: Patients with allergies to FOLFOX medications, active infections, pregnancy/breastfeeding, severe kidney or liver problems, or other recent cancers.

Trial focus: The study determines the optimal dose of BOLD-100 with FOLFOX and evaluates tumor response.

Investigational treatments: BOLD-100 combined with FOLFOX chemotherapy.

Study of E7386 and Lenvatinib for Patients with Liver, Colon, Endometrial, or Other Solid Tumors

This trial tests E7386, an investigational medication, alone and combined with lenvatinib (Lenvima) for patients with various solid tumors, including colorectal cancer. The study evaluates safety, tolerability, and determines the optimal dose.

Main inclusion criteria: Patients must be at least 18 years old with measurable disease, ECOG performance status 0-1, adequate organ function, and documented disease progression after previous treatments.

Main exclusion criteria: Patients with active brain metastases, prior treatment with topoisomerase inhibitors as adjuvant therapy, or belonging to vulnerable populations.

Trial focus: The study monitors tumor response and assesses long-term treatment effects over up to 26 weeks.

Investigational treatments: E7386 and lenvatinib (Lenvima).

Study of Flu Vaccine and Pembrolizumab for Patients with Early Colorectal Cancer

This trial tests a unique approach combining intratumoral flu vaccine injection with pembrolizumab (an immunotherapy) for patients with pMMR colorectal cancer. The study aims to determine if this combination can enhance the immune system’s ability to attack cancer cells.

Main inclusion criteria: Patients must have stage I-III colorectal adenocarcinoma, be 18 years or older, have ECOG performance status 0-1, adequate organ and bone marrow function, and be candidates for curative surgery.

Main exclusion criteria: Patients with other recent cancers, serious heart problems, or active infections.

Trial focus: The study evaluates immune response and tumor shrinkage before surgery.

Investigational treatments: Flu vaccine (intratumoral injection) combined with pembrolizumab (immunotherapy).

Study of IPN01194 for Adults with Advanced Solid Tumors, Including Melanoma, Head and Neck Cancer, Pancreatic Cancer, and Colorectal Cancer

This trial investigates IPN01194, an ERK1/2 inhibitor, for patients with advanced solid tumors, including colorectal cancer. The study is divided into dose-finding and efficacy evaluation phases.

Main inclusion criteria: Patients must be at least 18 years old with confirmed metastatic solid tumors, measurable disease according to RECIST v1.1, and ECOG performance status 0-1.

Main exclusion criteria: Patients not diagnosed with the specific cancers being studied or not meeting age requirements.

Trial focus: The study determines the safe dosage and monitors antitumor activity.

Investigational treatment: IPN01194 (ERK1/2 inhibitor).

Summary

The clinical trials for colorectal cancer demonstrate significant geographic concentration, with the majority of studies conducted in European countries, particularly Belgium, France, Germany, Italy, Netherlands, and Spain. Several trials are also ongoing in the Nordic countries (Denmark, Finland, Norway, Sweden).

A notable focus across trials is on immunotherapy combinations, with multiple studies investigating pembrolizumab, nivolumab, atezolizumab, and other checkpoint inhibitors. Many trials target specific genetic mutations, particularly KRAS G12C, BRAF V600E, MSI-H/dMMR, and RAS/MAPK pathway alterations. This reflects the increasingly personalized approach to colorectal cancer treatment.

Several trials combine immunotherapy with targeted therapies and chemotherapy regimens such as FOLFOX, FOLFIRI, and bevacizumab. The trials demonstrate innovation in treatment delivery methods, including novel approaches like intratumoral flu vaccine combined with immunotherapy and pressurized intraperitoneal aerosol chemotherapy (PIPAC).

Many studies focus on advanced or metastatic disease, though some address earlier stages and organ preservation strategies. Pain management after colorectal surgery is also being studied, reflecting attention to quality of life issues. The diversity of treatment approaches and geographic distribution suggests robust international collaboration in advancing colorectal cancer treatment options.

Ongoing Clinical Trials on Colorectal cancer

  • Study on Oxaliplatin and Irinotecan for Patients with Metastatic Colorectal Cancer in the Liver

    Recruiting

    1 1 1 1
    Investigated diseases:
    Investigated drugs:
    Belgium France

  • Study on STC-1010 and Drug Combination for Patients with Advanced or Metastatic Colorectal Cancer

    Recruiting

    1 1 1
    Investigated diseases:
    Investigated drugs:
    Belgium France

  • Study of BOLD-100 with FOLFOX chemotherapy (fluorouracil, folinic acid, and oxaliplatin) in patients with advanced gastrointestinal tumors, colorectal, gastric, or pancreatic cancer

    Recruiting

    1 1 1
    Investigated diseases:
    Investigated drugs:
    Germany Ireland Italy Spain

  • Study of E7386 and Lenvatinib for Patients with Liver, Colon, Endometrial, or Other Solid Tumors

    Recruiting

    1 1 1
    Investigated diseases:
    Investigated drugs:
    Denmark France Italy Spain

  • Study on Long-Term Safety of Trastuzumab Deruxtecan for Patients with Advanced HER2-Positive or HER2-Mutated Solid Tumors

    Recruiting

    1 1 1
    Investigated diseases:
    Investigated drugs:
    Belgium France Italy Spain

  • Study on the Safety and Effects of [68Ga]Ga-DPI-4452 and [177Lu]Lu-DPI-4452 in Patients with Advanced or Metastatic Solid Tumors

    Recruiting

    1 1 1
    Investigated diseases:
    Investigated drugs:
    Belgium France

  • Study on Tislelizumab for Cancer Patients with Molecular Residual Disease After Standard Treatment

    Recruiting

    1 1 1
    Investigated diseases:
    Investigated drugs:
    France

  • Study on the Effectiveness of Heated Chemotherapy with Mitomycin-C for Patients with Colon Cancer Spread to the Peritoneum After Surgery

    Recruiting

    1 1 1 1
    Investigated diseases:
    Investigated drugs:
    Spain

  • Study on Preventing Peritoneal Metastases in High-Risk Colorectal Cancer Patients Using Fluorouracil, Oxaliplatin, and Levoleucovorin After Surgery

    Recruiting

    1 1 1
    Investigated diseases:
    Investigated drugs:
    Italy

  • Study on Using ctDNA to Guide Treatment in Patients with Metastatic Colorectal Cancer Using Oxaliplatin, Capecitabine, Calcium Folinate, Irinotecan, and Fluorouracil

    Recruiting

    1 1 1
    Investigated diseases:
    Investigated drugs:
    Denmark Germany Norway

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